Rational and irrational use of nonsterile compounded medications

Nonsterile compounding is a fundamental component of pharmacy practice, and compounded medications are sometimes essential to optimize a patient's medication therapy. However, controversies surround the rational use of nonsterile compounded medications. Factors including drug cost and availability and the need for a precise dosage or unique formulation may provide a legitimate reason to prepare a compounded medication. Nonetheless, clinical pharmacists should ensure a rational basis for the use of such preparations. The relative paucity of data surrounding the regulation of these formulations, as well as that surrounding their promotion and production, complicates the evaluation of their safety and efficacy. This is especially true when compounded medications are used in special cases that already lack data for the use of commercially available products. Ethical issues also surround the rational use of these nonsterile compounded medications, including the absence of their proven safety and efficacy, the lack of regulation of promotional practices regarding their use, the pricing associated with them, the strategies needed to obtain third-party coverage for them, and the limited standards in place for the actual production of compounded medications. Indeed, more evidence documenting the safety and efficacy of compounded medications is needed, together with standardization of formulations and better regulation of promotional practices and qualifications of compounding personnel. ACCP supports increased regulation of compounding to promote the appropriate use of these preparations.